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Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response

PURPOSE: Food and Drug Administration’s (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge–attitudes–behaviors (KAB) surveys as regulatory science tools. This mixed-methods evaluation a...

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Detalles Bibliográficos
Autores principales:	Brewer, Sarah E., Campagna, Elizabeth J., Morrato, Elaine H.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Cambridge University Press 2019
Materias:	Research Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6799639/ https://www.ncbi.nlm.nih.gov/pubmed/31660244 http://dx.doi.org/10.1017/cts.2019.400

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